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Public hearing highlights FDA's role in global health

Building regulatory capacity, strengthening partnerships

On September 23, the FDA hosted a pivotal public hearing to examine its role in regulating and reviewing global health technologies, such as vaccines, drugs, microbicides, diagnostics, and other tools that save lives worldwide. The hearing was hosted by the agency's newly mandated review group for neglected diseases of the developing world in preparation for a report the group will deliver to Congress next year on the topic.

The Global Health Technologies Coalition (GHTC) and representatives from other leading global health organizations testified at the hearing. Speakers offered several recommendations for an expansion of the FDA’s effort to advance global health products.

Speakers proposed that the FDA strengthen its engagement with groups and entities, such as product development partnerships (PDPs), developing the tools to prevent, diagnose, and treat diseases of the developing world. Several speakers noted that it is crucial for the FDA to engage with non-traditional product sponsors, including PDPs, at several stages of product development so that the agency can serve as a mentor to these groups on regulatory issues.

Speakers urged the FDA to help build regulatory capacity in developing nations through increased collaboration with countries and regional regulatory networks. Many countries in the developing world do not have the capacity or resources to regulate health tools and ensure that only safe and effective products are distributed to people in need.

Speakers encouraged the FDA to bolster its partnership with global regulatory stakeholders, such as the World Health Organization (WHO). Stronger association between the FDA and partners such as the WHO can help streamline the review of new global health tools and reduce the time it takes for lifesaving medical products to reach people in need.

Finally, speakers highlighted how incentive mechanisms, particularly the FDA's Priority Review Voucher (PRV) program, can help spur the development of new tools for diseases of the developing world.

The hearing was "extremely helpful" to the FDA's neglected disease review group, Leonard Sacks—acting director of the agency's Office of Critical Path Programs—said. He added that the hearing was only the "beginning of a process" and that there is "a lot of work ahead” for the FDA and its partners to help ensure the safety of health tools to prevent, diagnose, and treat infectious diseases that affect millions of people worldwide every year.